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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device c-reactive protein, antigen, antiserum, and control
Product CodeDCK
Regulation Number 866.5270
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 2
ORION DIAGNOSTICA OY
  SUBSTANTIALLY EQUIVALENT 1
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
PROCISE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
QUALIGEN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH, SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Apr-25-2013
2 Beckman Coulter Inc III Mar-02-2010
3 Kamiya Biomedical Company, LLC II Mar-04-2010
4 Medtest Holdings, Inc. III Jun-26-2017
5 Ortho-Clinical Diagnostics III Dec-21-2016
6 Ortho-Clinical Diagnostics II Nov-15-2013
7 Ortho-Clinical Diagnostics III Jun-27-2013
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